Individualized vs Standard Ventilation for Surgery

Overseen By William G Tharp, MD PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Vermont Medical Center

Disqualifiers: Current smoker, Lung disease, Cardiac impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

50 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this clinical trial is to determine whether different types of ventilator settings during surgery change the relationship between the pressures in the lungs and the function of the heart. In this study, patients will be randomly assigned (like flipping a coin) to receive either standard or individualized (research) lung protective ventilator settings. Before surgery, patients will be given an 8-item verbal questionnaire about any respiratory symptoms. After patients are asleep for surgery, an ultrasound probe will be inserted into the esophagus (food pipe) and stomach to examine the heart and lungs and take ultrasound pictures. The ultrasound probe is then removed. Next, a small balloon catheter (a narrow tube smaller in diameter than a pencil lead) will be placed in the esophagus, where it will be used to measure the pressures in the chest and lungs. For patients who are assigned to standard ventilator settings, the ventilator settings and pressures during surgery will be recorded. For patients assigned to individualized (research) ventilator settings, the pressures from the balloon catheter will be used to adjust the ventilator settings every 30 minutes during surgery. A second ultrasound pictures of the heart and lungs will be obtained at the point at which the patient is placed into the Trendelenburg position. At the end of surgery and before the patient is awake, the balloon catheter will be removed, the ultrasound probe will be inserted, a third set of ultrasound pictures of the heart and lungs will be obtained, and the ultrasound probe then removed. Patients will be telephoned 30 days after surgery to ask about their recovery. The 8-item respiratory symptom questionnaire will be repeated at this time.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment Balloon Catheter Placement, Telephonic Follow-up, Transpulmonary Pressure Guided Ventilation, Ultrasound Probe Insertion?

Research shows that using individualized ventilation strategies, like transpulmonary pressure-guided ventilation, can improve lung function and reduce complications during surgery, especially in patients with conditions like acute respiratory distress syndrome (ARDS). This suggests that tailoring ventilation to individual needs may enhance outcomes in surgical settings. ^{1 2 3 4 5}

Is individualized ventilation generally safe for surgery?

Research suggests that individualized ventilation strategies, like driving pressure-guided ventilation, can reduce complications and improve outcomes in surgeries, indicating they are generally safe for use in humans. ^{1 4 5 6 7}

How does Transpulmonary Pressure Guided Ventilation differ from standard treatments for surgery?

Transpulmonary Pressure Guided Ventilation is unique because it personalizes the mechanical ventilation settings based on individual lung characteristics, such as lung physiology and morphology, rather than using a one-size-fits-all approach. This method aims to optimize ventilation by adjusting parameters like tidal volume and positive end-expiratory pressure (PEEP) to minimize lung injury and improve outcomes. ^{1 2 3 8 9}

Research Team

William G Tharp, MD PhD

Principal Investigator

University of Vermont Medical Center

Eligibility Criteria

This trial is for adults over 18 who are having robotic-assisted laparoscopic surgery in a specific position at the University of Vermont Medical Center. They must be able to give consent and speak English. Smokers, those with significant past smoking history, lung diseases like asthma or COPD, heart problems, esophageal issues, or other conditions that could affect participation are excluded.

Inclusion Criteria

I am having robotic surgery in a specific position at the University of Vermont Medical Center.

Signed consent form

Exclusion Criteria

Any other co-morbid condition that, in the opinion of the study investigators, may interfere with study participation

I need surgery urgently.

Smoking history ≥20 pack years

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Preoperative Assessment

Measurement of the patient's waist size and weight, and administration of an 8-item verbal questionnaire about respiratory symptoms

1 day

1 visit (in-person)

Intraoperative Procedure

Patients undergo surgery with either standard or individualized lung protective ventilator settings, with ultrasound exams and pressure measurements

Duration of surgery

Postoperative Follow-up

Patients are telephoned 30 days after surgery to ask about their recovery and repeat the 8-item respiratory symptom questionnaire

30 days post-surgery

1 visit (virtual)

Treatment Details

Interventions

• Balloon Catheter Placement
• Telephonic Follow-up
• Transpulmonary Pressure Guided Ventilation
• Ultrasound Probe Insertion

Trial Overview The study tests if different ventilator settings during surgery can influence how pressures in the lungs affect heart function. Patients will either receive standard ventilation or individualized adjustments based on pressure measurements taken every 30 minutes with a balloon catheter. Heart and lung function will be monitored using ultrasound before and after surgery.

Participant Groups

Group I: Individualized lung protective ventilator settings Experimental Treatment 1 Intervention

Lung-protective ventilator settings will be individualized based on the patient's transpulmonary pressures (TPP), as measured by esophageal manometry.

Group II: Standard lung protective ventilator settings Active Control 1 Intervention

Ventilator settings will be adjusted to standard lung-protective settings according to the anesthesiologist's clinical judgement for the patient, their comorbodities, and the surgical procedure.

Who Is Running the Clinical Trial?

University of Vermont Medical Center

Lead Sponsor

Trials

46

Recruited

25,900+

Findings from Research

In a study of 30 patients undergoing thoracic surgery, individualized positive end-expiratory pressure (PEEP) significantly improved oxygenation and lung mechanics during one-lung ventilation compared to a standardized PEEP of 5 cm·H2O.

The study group maintained higher arterial oxygenation levels (306 mm·Hg) and showed significant improvements in static compliance after adjusting PEEP, while the control group experienced decreased oxygenation, highlighting the efficacy of individualized PEEP in enhancing respiratory function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Setting individualized positive end-expiratory pressure level with a positive end-expiratory pressure decrement trial after a recruitment maneuver improves oxygenation and lung mechanics during one-lung ventilation. Ferrando, C., Mugarra, A., Gutierrez, A., et al.[2022]

A personalized mechanical ventilation strategy for patients with ARDS, which considers lung physiology, imaging, and biological phenotypes, may enhance treatment outcomes, but more research is needed before implementation in clinical settings.

Monitoring specific ventilatory parameters, such as low tidal volume and driving pressures, along with techniques like esophageal pressure monitoring, can help tailor ventilation settings to individual patient needs, potentially improving safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized mechanical ventilation in acute respiratory distress syndrome. Pelosi, P., Ball, L., Barbas, CSV., et al.[2021]

Mechanical ventilation can either worsen lung injury in patients with or at risk for ARDS or help reduce mortality if properly adjusted, highlighting the importance of personalized ventilation strategies.

Current practices often use a standard approach for setting tidal volume and PEEP, but evidence suggests that optimizing PEEP based on individual lung pathology rather than solely on oxygenation could improve patient outcomes, though no consensus exists on the best method for personalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalizing mechanical ventilation according to physiologic parameters to stabilize alveoli and minimize ventilator induced lung injury (VILI). Nieman, GF., Satalin, J., Andrews, P., et al.[2020]

A multicenter trial involving 420 patients with moderate-to-severe ARDS found that personalizing mechanical ventilation based on lung morphology did not significantly reduce 90-day mortality compared to standard care (hazard ratio 1.01).

Misclassification of patients' lung morphology was common (21%), and those misclassified had higher mortality rates when treated with personalized ventilation, suggesting that accurate phenotyping of ARDS is crucial for effective treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalised mechanical ventilation tailored to lung morphology versus low positive end-expiratory pressure for patients with acute respiratory distress syndrome in France (the LIVE study): a multicentre, single-blind, randomised controlled trial. Constantin, JM., Jabaudon, M., Lefrant, JY., et al.[2020]

References

1. China pubmed.ncbi.nlm.nih.gov

[Effect of different transpulmonary pressures guided mechanical ventilation on respiratory and hemodynamics of patients with ARDS: a prospective randomized controlled trial]. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Setting individualized positive end-expiratory pressure level with a positive end-expiratory pressure decrement trial after a recruitment maneuver improves oxygenation and lung mechanics during one-lung ventilation. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Personalized mechanical ventilation in acute respiratory distress syndrome. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Rationale and Study Design for an Individualized Perioperative Open Lung Ventilatory Strategy in Patients on One-Lung Ventilation (iPROVE-OLV). [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Driving Pressure-Oriented Ventilation on Patients Undergoing One-Lung Ventilation During Thoracic Surgery: A Systematic Review and Meta-Analysis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

The effect of driving pressure-guided versus conventional mechanical ventilation strategy on pulmonary complications following on-pump cardiac surgery: A randomized clinical trial. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Association of Intraoperative Ventilator Management With Postoperative Oxygenation, Pulmonary Complications, and Mortality. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

Personalizing mechanical ventilation according to physiologic parameters to stabilize alveoli and minimize ventilator induced lung injury (VILI). [2020]

9. England pubmed.ncbi.nlm.nih.gov

Personalised mechanical ventilation tailored to lung morphology versus low positive end-expiratory pressure for patients with acute respiratory distress syndrome in France (the LIVE study): a multicentre, single-blind, randomised controlled trial. [2020]